Description and Brand Names

US Brand Name

Kaletra

Descriptions

Lopinavir and ritonavir combination is used in the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus responsible for acquired immune deficiency syndrome (AIDS). It is used to slow the progression of disease in patients infected with HIV who have advanced symptoms, early symptoms, or no symptoms at all.

Lopinavir and ritonavir combination will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease. Lopinavir and ritonavir combination will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Tablet

Capsule, Liquid Filled

Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of lopinavir and ritonavir combination in infants younger than 14 days of age. Safety and efficacy have not been established. Kaletra® should not be used once a day in children. Kaletra® oral liquid should not be given to premature infants.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lopinavir and ritonavir combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution in patients receiving lopinavir and ritonavir combination.

Pregnancy

Information about this lopinavir-and-ritonavir-oral-route

Pregnancy Category

Explanation

All Trimesters

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Alfuzosin

Amifampridine

Amiodarone

Astemizole

Bepridil

Cisapride

Colchicine

Conivaptan

Crizotinib

Dabrafenib

Dihydroergotamine

Doxorubicin

Doxorubicin Hydrochloride Liposome

Dronedarone

Eletriptan

Encainide

Eplerenone

Ergoloid Mesylates

Ergonovine

Ergotamine

Eszopiclone

Everolimus

Fentanyl

Flecainide

Fluconazole

Ibrutinib

Ivabradine

Ketoconazole

Lomitapide

Lovastatin

Lurasidone

Maraviroc

Mesoridazine

Methylergonovine

Methysergide

Midazolam

Naloxegol

Nelfinavir

Nimodipine

Pimozide

Piperaquine

Posaconazole

Primidone

Propafenone

Quetiapine

Quinidine

Ranolazine

Rifampin

Riociguat

Romidepsin

Sildenafil

Silodosin

Simvastatin

Sparfloxacin

St John's Wort

Suvorexant

Terfenadine

Tolvaptan

Trabectedin

Triazolam

Vemurafenib

Vilazodone

Vinflunine

Vorapaxar

Voriconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Ado-Trastuzumab Emtansine

Afatinib

Amiodarone

Amitriptyline

Amoxapine

Anagrelide

Apixaban

Apomorphine

Aprepitant

Aripiprazole

Arsenic Trioxide

Artemether

Asenapine

Atorvastatin

Avanafil

Axitinib

Azithromycin

Bedaquiline

Bepridil

Boceprevir

Bosentan

Bosutinib

Brentuximab Vedotin

Bromocriptine

Budesonide

Bupropion

Buserelin

Cabazitaxel

Cabozantinib

Canagliflozin

Carbamazepine

Ceritinib

Chloroquine

Chlorpromazine

Ciprofloxacin

Citalopram

Clarithromycin

Clomipramine

Clozapine

Cobicistat

Cyclophosphamide

Dabigatran Etexilate

Daclatasvir

Darunavir

Dasatinib

Delamanid

Desipramine

Deslorelin

Dexamethasone

Digoxin

Docetaxel

Dofetilide

Dolasetron

Domperidone

Doxorubicin

Doxorubicin Hydrochloride Liposome

Droperidol

Enzalutamide

Erlotinib

Erythromycin

Escitalopram

Eslicarbazepine Acetate

Etravirine

Fingolimod

Fluconazole

Fluoxetine

Fluticasone

Fosphenytoin

Fusidic Acid

Garlic

Gatifloxacin

Gemifloxacin

Gonadorelin

Goserelin

Granisetron

Halofantrine

Haloperidol

Histrelin

Hydrocodone

Ibutilide

Idelalisib

Ifosfamide

Iloperidone

Irinotecan

Ivacaftor

Ixabepilone

Ketoconazole

Lacosamide

Lapatinib

Leuprolide

Levofloxacin

Levomilnacipran

Lidocaine

Lumefantrine

Macitentan

Mefloquine

Methylenedioxymethamphetamine

Metronidazole

Mifepristone

Mitotane

Morphine

Morphine Sulfate Liposome

Moxifloxacin

Nafarelin

Nilotinib

Nintedanib

Norfloxacin

Nortriptyline

Octreotide

Ofloxacin

Ondansetron

Oxycodone

Paliperidone

Pasireotide

Pazopanib

Perflutren Lipid Microsphere

Phenobarbital

Phenytoin

Piperaquine

Pixantrone

Pomalidomide

Ponatinib

Prednisolone

Prednisone

Procainamide

Promethazine

Propafenone

Protriptyline

Quinidine

Quinine

Regorafenib

Retapamulin

Rifabutin

Rifampin

Rifapentine

Rivaroxaban

Rosuvastatin

Ruxolitinib

Salmeterol

Saquinavir

Sertraline

Sevoflurane

Siltuximab

Simeprevir

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Solifenacin

Sorafenib

Sotalol

Sunitinib

Tadalafil

Tamoxifen

Tamsulosin

Telaprevir

Telavancin

Telithromycin

Temsirolimus

Tetrabenazine

Ticagrelor

Tipranavir

Topotecan

Toremifene

Trazodone

Triamcinolone

Trifluoperazine

Trimipramine

Triptorelin

Vandetanib

Vardenafil

Venlafaxine

Vilanterol

Vinblastine

Vincristine

Vincristine Sulfate Liposome

Voriconazole

Ziprasidone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acenocoumarol

Alprazolam

Amitriptyline

Amlodipine

Amprenavir

Atazanavir

Cerivastatin

Clonazepam

Cyclosporine

Dalfopristin

Delavirdine

Desipramine

Desogestrel

Didanosine

Dienogest

Diltiazem

Disopyramide

Drospirenone

Dutasteride

Efavirenz

Eltrombopag

Estradiol Cypionate

Estradiol Valerate

Ethinyl Estradiol

Ethynodiol Diacetate

Etonogestrel

Fosamprenavir

Gemfibrozil

Imipramine

Indinavir

Itraconazole

Lamotrigine

Levonorgestrel

Levothyroxine

Medroxyprogesterone Acetate

Meperidine

Mestranol

Methadone

Methamphetamine

Mexiletine

Nefazodone

Nelfinavir

Nevirapine

Norelgestromin

Norethindrone

Norgestimate

Norgestrel

Paroxetine

Phenobarbital

Prasugrel

Quinupristin

Risperidone

Tacrolimus

Tenofovir Disoproxil Fumarate

Theophylline

Trazodone

Valproic Acid

Verapamil

Warfarin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Cirrhosis (liver disease) or

Diabetes mellitus or

Hemophilia (a bleeding problem) or

Hyperglycemia (high blood sugar) or

Hyperlipidemia (high cholesterol or fat in the blood) or

Liver disease (e.g., hepatitis B or C) or

Pancreatitis, history of—Use with caution. May make these conditions worse.

Heart attack, history of or

Heart disease (e.g., cardiomyopathy, ischemic heart disease), history of or

Heart rhythm problems (e.g., prolonged PR or QT interval, congenital long QT syndrome), history of or

Hypokalemia (low potassium in the blood)—Use with caution. May increase risk for more serious side effects.

Proper Use

Take this medicine exactly as directed by your doctor. Do not change the dose or stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. If you need help in planning the best times to take your medicine, check with your doctor.

Lopinavir and ritonavir combination will always be given with other medicines for HIV. Take all of the medicines your doctor has prescribed as part of your combination treatment. Do not stop using your medicine unless your doctor tells you to.

It is important that lopinavir and ritonavir oral liquid be taken with food. Use a calibrated dosing syringe or medicine cup to measure the dose for the oral liquid.

Lopinavir and ritonavir tablets may be taken with or without food. Swallow the tablets whole; do not crush, break, or chew them.

This medicine comes with a Medication Guide and patient information leaflet. Read and follow these instructions carefully before starting treatment and each time you refill your prescription. Ask your doctor if you have any questions.

If you are also using didanosine (Videx®), take it one hour before or two hours after taking Kaletra® oral liquid. Didanosine can be taken (without food) at the same time as Kaletra® tablets.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For treatment of HIV infection:

For oral dosage form (solution):

Adults—400 milligrams (mg) of lopinavir and 100 mg of ritonavir (5 milliliters [mL]) two times per day with food or 800 mg of lopinavir and 200 mg of ritonavir (10 mL) once a day with food. Your doctor may adjust your dose as needed.

Children and infants 6 months to 18 years of age—Dose is based on body weight or body size and must be determined by your child's doctor. The recommended dose is 10 to 12 milligrams per kilogram (mg/kg) of body weight or 230 milligrams per square meter (mg/m[2]) of body size for lopinavir and 2.5 to 3 mg/kg or 57.5 (mg/m[2]) for ritonavir two times per day with food. Your doctor may adjust your dose as needed.

Infants 14 days to 6 months of age—Dose is based on body weight or body size and must be determined by your child's doctor. The recommended dose is 16 milligrams per kilogram (mg/kg) of body weight or 300 milligrams per square meter (mg/m[2]) of body size for lopinavir and 4 mg/kg or 75 (mg/m[2]) for ritonavir two times per day with food.

Infants younger than 14 days of age—Use is not recommended unless your doctor determines it is safe to administer.

For oral dosage form (tablets):

Adults—400 milligrams (mg) of lopinavir and 100 mg of ritonavir (2 tablets) two times per day or 800 mg of lopinavir and 200 mg of ritonavir (4 tablets) once a day. Your doctor may adjust your dose as needed.

Children and infants 6 months to 18 years of age—The child must be able to swallow a tablet whole. Dose is based on body weight and must be determined by your child's doctor. The recommended dose is 200 to 400 milligrams (mg) of lopinavir and 50 to 100 mg of ritonavir (2 to 4 tablets) two times per day. Your doctor may adjust your dose as needed.

Infants 14 days to 6 months of age—This dosage form is usually not used for infants. Please refer to the oral solution dosage form.

Infants younger than 14 days of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

It is best to store the Kaletra® oral liquid in a closed container in the refrigerator. Do not freeze. If you must store the liquid at room temperature, use the medicine within 2 months and keep it away from excessive heat.

The Kaletra® tablets should be stored in a closed container at room temperature, away from heat, moisture, and direct light.

Precautions

It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, and herbal (e.g., St. John's wort) or vitamin supplements.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

Pancreatitis may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may increase blood sugar levels. Check with your doctor if you or your child notice a change in the results of your blood or urine sugar tests.

This medicine can cause changes in heart rhythms, such as a condition called PR or QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you or your child have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

This medicine may increase the level of cholesterol and fats in your blood. If this condition occurs, your doctor may give you a medicine to lower the cholesterol and fats. Talk to your doctor if you or your child have concerns.

If you or your child develop a skin rash, hives, or any allergic reaction to this medicine, stop taking the medicine and check with your doctor as soon as possible.

If you are taking the oral liquid, you should limit the amount of alcohol you drink. The Kaletra® oral liquid contains 42% alcohol. Talk to your doctor if you or your child are taking, or plan to take, metronidazole (Flagyl®) or disulfiram (Antabuse®).

Birth control pills that contain estrogen may not work as well while you are using this medicine. To keep from getting pregnant, use a second type of birth control together with the pills. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.

When you start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body, such as pneumonia or tuberculosis, you or your child may notice new symptoms when your body tries to fight them. If this occurs, be sure to tell your doctor.

This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Bloating

blurred vision

chills

constipation

darkened urine

dry mouth

fast heartbeat

fever

flushed, dry skin

fruit-like breath odor

increased hunger

increased thirst

increased urination

indigestion

loss of appetite

loss of consciousness

nausea

pains in the stomach, side, or abdomen, possibly moving to the back

sweating

troubled breathing

unexplained weight loss

vomiting

yellow eyes or skin

Incidence not known

Blistering, peeling, or loosening of the skin

chest pain or discomfort

cough

diarrhea

itching

joint or muscle pain

lightheadedness, dizziness, or fainting

red skin lesions, often with a purple center

red, irritated eyes

shortness of breath

slow or irregular heartbeat

sore throat

sores, ulcers, or white spots in the mouth or on the lips

unusual tiredness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Abnormal stools

acid or sour stomach

belching

headache

heartburn

lack or loss of strength

pain

skin rash

stomach discomfort, upset, or pain

trouble with sleeping

Incidence not known

Redistribution of body fat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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